Senior Statistical Programmer

Job Title Senior Statistical ProgrammerJob Location Bengaluru Karnataka IndiaJob Location Type On-siteJob Contract Type Full-timeJob Seniority Level Mid-Senior leveleClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud the foundation of digital trials Together the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter faster business decisions OverviewStatistical Programmers provide SAS programming expertise in data extracted from various databases for data transformation of raw data Develop specifications and programming expertise and validation for Study Data Tabulation Model SDTM datasets Analysis Data Model ADaM datasets and develop programming to produce Tables Listings and Graphs Figures TLGs or TLFs and other reports to support statistical analysis Key Tasks Responsibilities Develop specifications for SDTM datasets and SDTM datasets specifications for Clinical Data Analysis Develop SAS programming to produce SDTM datasets and SDTM datasets Develop specifications for Analysis Data Model ADaM datasets Develop SAS programming and validation of ADaM datasets for trial level reporting and integrated safety and efficacy activities Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials Program and QC data listings summaries and Graphs as defined in SAP If required validate the statistical models used for programming Develop re-usable utility macros to build a macro library to support programming tables listing and graphs for phase 1-4 clinical trial reporting Collaborate with the project team to ensure the deliverables are completed on time and with high quality Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC Maintain all project documentation as required by SOP and Processes Mentor statistical programmers Ensure compliance with eClinical Solutions and industry quality standards guidelines and procedures Other duties as assigned Education Language Basic Science Bachelor of Science degree Master in Statistics or related science preferred in health-related field computer science or equivalent SAS Certified Excellent knowledge of English Professional Skills Experience Minimum 6 years in Pharmaceutical Biotechnology industry or equivalent IT consulting role Strong experience in preparations for NDA filings Strong knowledge of E6 E3 E9 guidelines 21 CFR Part 11 and clinical trial methodologies Knowledge of coding dictionaries WHO COSTART ICD-9 MedDRA Knowledge of CDISCxc2xae related data models like SDTM and ADAM Experience of working on multiple clinical protocols at the same time Excellent verbal and written communication skills Detail oriented ability to multitask with strong prioritization planning and organization skills Excellent team player Technical Skills Experience Experience of extracting manipulating merging summarizing analyzing and presenting data using SAS procedures Strong experience of base SAS programming Proc SQL macro programming ODS and various SAS modules SAS GRAPH SAS STAT and other modules like SAS Connect and SAS Access is a must Experience with reporting environments and reporting tools related to SAS programming in pharmaceutical industry proc report proc summary and proc tabulate Strong experience in SAS programming in various phases of clinical trial Experience in pooled data analysis and programming Strong experience in efficacy reporting with regards to development of analysis sets and treating missing values Experience in working with relational databases and performance tuning of SAS programming Experience with writing batch scripts and or shell scripts is a plus Accelerate your skills and career within a fast-growing company while impacting the future of healthcare We have shared our story now we look forward to learning yours eClinical Solutions is a people first organization Our inclusive culture values the contribution that diversity brings to our business We celebrate individual experiences that connect us and that inspire innovation in our community Our team seeks out opportunities to learn grow and continuously improve Bring your authentic self you are welcome here We are proud to be an equal opportunity employer that values diversity Our management team is committed to the principle that employment decisions are based on qualifications merit culture fit and business need Lifelancer is a talent-hiring platform in Life Sciences Pharma and IT The platform connects talent with opportunities in pharma biotech health sciences 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